Registration Dossier
Registration Dossier
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EC number: 233-899-5 | CAS number: 10421-48-4
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Publication, reasonably documented, acceptable for assessment.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Safe Upper levels for Vitamins and Minerals
- Author:
- EVM; Expert Group on Vitamins and Minerals
- Year:
- 2 003
- Bibliographic source:
- http://www.food.gov.uk/multimedia/pdfs/vitmin2003.pdf
Materials and methods
- Study type:
- other: published review
- Endpoint addressed:
- other: establishment of safe limit for humans
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Review: with the aim of establishing a safe limit for human dietary exposure
- GLP compliance:
- no
Test material
- Reference substance name:
- Iron sulphate
- EC Number:
- 231-753-5
- EC Name:
- Iron sulphate
- Cas Number:
- 7720-78-7
- IUPAC Name:
- iron(2+) sulfate
- Test material form:
- not specified
- Details on test material:
- Iron sulphate
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not applicable
- Route of exposure:
- oral
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- This published review aimed to establish safe upper levels for iron intake based on its biological function, extent of absorption, toxicity and effects of deficiency in humans.
- Executive summary:
A review of the safety of vitamin and mineral supplements in food looked at: exposure to iron; the biological function of iron; iron deficiency; interactions with other metals; absorption and bioavailability; distribution, metabolism and excretion; toxicity. Guidance levels were established. The review reported average daily losses of 1.0 mg/day in healthy adult male humans, and 1.3 mg/day in pre-menopausal women. The acute doses were considered to be: 20 mg/kg for infants (under the age of six) by gastrointestinal irritation, with systemic effects not occurring below 60mg/kg bw; 200-300 mg/kg for children; 1400 mg/kg bw for adults. It was considered that there is not enough evidence to reach conclusions on specific links between iron and development of cancers.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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